Build compliance and ethical foundations in Medical Affairs.
Operating ethically and within regulatory frameworks is fundamental to effective Medical Affairs practice. This course provides a structured introduction to compliance, governance, and ethical principles, equipping participants with the knowledge and awareness required to navigate the complex regulatory environment.
Why enrol?
Medical Affairs professionals work in a highly regulated environment where inappropriate actions—intentional or otherwise—can have significant legal, reputational, and patient safety implications. Many early-career professionals lack formal training in compliance and ethical decision-making. This course establishes the essential foundations needed to work responsibly and confidently.
What will you learn?
Participants will develop a practical understanding of:
- Quality Use of Medicines (QUM) and its role in safe and effective care
- Patient safety principles and pharmacovigilance obligations
- Industry Codes of Conduct (e.g. Medicines Australia Code)
- Ethical decision-making in Medical Affairs contexts
- Equity, diversity and inclusion (EDI) in healthcare environments
- Key legal concepts including confidentiality, privacy, intellectual property, and copyright
Through scenario-based learning and guided activities, participants will build awareness of compliance boundaries, appropriate behaviours, and when to escalate issues or seek advice.
Course Highlights
- Designed specifically for Medical Affairs professionals and those transitioning into the field
- Self-paced online delivery with flexible access
- Focus on real-world compliance scenarios and ethical challenges
- Builds a solid foundation for responsible professional practice
Who Should Attend
- Medical Affairs professionals (MSLs, Advisors, Managers)
- Professionals transitioning into Medical Affairs roles
- Healthcare or industry professionals seeking compliance knowledge
Develop the awareness and judgement required to work ethically, mitigate or avoid risk, and contribute to high-quality, compliant Medical Affairs practice.
Topics
- Quality Use of Medicines (QUM)
- Patient safety and pharmacovigilance
- Industry Codes of Conduct
- Ethical decision-making frameworks
- Equity, diversity and inclusion (EDI)
- Legal foundations (privacy, confidentiality, IP, copyright)
- Governance and escalation processes
Learning Outcomes
By the end of this course you will be able to:
• Explain principles of QUM and their relevance to Medical Affairs
• Identify requirements of industry Codes of Conduct and escalation points
• Recognise key legal concepts relevant to Medical Affairs activities
• Apply ethical reasoning and EDI principles in workplace scenarios
Course delivery method
Fully online, self-paced (asynchronous) on-demand learning. Participants may start at any time and complete the course at their own pace, within the specified course availability period. Pre-recorded lectures, interactive learning activities.
Course pre-requisites
Additional course information
Aligned to MAPA Competency Framework.
Participants must successfully complete at least 80% of the program to be eligible for completion recognition. Progression through the content will be tracked, and participants will be required to submit a self-declaration at the conclusion of the program confirming that this completion threshold has been met. This declaration may be independently verified by the University if required. Upon successful completion of the program, participants will be issues with a Certificate of Completion from the University of Sydney.
Aligned with the MAPA Working Group - Medical Affairs Competency Framework.
Domain 1: Scientific and Technical Knowledge
Domain 2: Evidence Generation
Domain 3: Compliance and Ethics
Domain 4: Leadership and Professionalism
Domain 5: Communication and Collaboration
Domain 6: Business Knowledge
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| Course fees |
| Standard |
$1,700 |
| Alumni/Staff |
$1,530 |